Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

FDA Letters Made Public Are Creating New Risks

There is a pharma-backed citizen petition challenging the FDA over its new practice of publicly releasing redacted Complete Response Letters (CRLs). It could potentially end in a lawsuit. Chief Editor Louis Garguilo provides early analysis of what is at stake.

GUEST COLUMNISTS

Validating Candel's BLA-Ready Analytics Profile
The adenovirus/prodrug company discusses in-house assay development and the validation work to confirm CQAs like potency and cell line integrity.
Mapping Candel Therapeutics' Sprint To The BLA Finish Line
Leaders from the adenovirus/prodrug developer discuss the complex balancing act of preparing to scale up for commercial manufacturing without overextension.
The Hidden Operational Cost Contained In Every Small Molecule Portfolio
The volume of post-approval changes is rising and the manual approaches that have worked until now are no longer adequate. Get ahead of this to spend less and execute faster.
Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation
Scientific and regulatory leaders in the Asia-Pacific region met recently for an exchange of strategies to strengthen convergence and technical competence.
U.S. Pharma Tariffs And MFN Become Law After April 2 Update
Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.
How To Implement Post-Approval Changes On A Global Level
To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.
March 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
The Business Case For Continuous Manufacturing In Biologics
The question for leadership is not if continuous manufacturing will transform biologics, but when and how quickly to invest.

PHARMA OUTSOURCING WHITE PAPERS

If You Can't Win The Game, Change It
Explore how eData sharing is used in the biopharma market, enabling standardized, collaborative supply chains that reduce risks and enhance visibility while improving capacity planning.

Modernizing Clinical Trial Logistics To Deliver Value
Explore how biopharma organizations can design and operate clinical supply systems that absorb complexity while maintaining control and consistency.
Transformative Innovation: Advancing Drug Development Using In Silico Modeling
Explore how predictive modeling and in silico strategies can turn complex data into actionable insights that accelerate drug development and reduce risk across the development lifecycle.
Key Selection Criteria For Cell & Gene Therapy CDMOs
Choosing the right CDMO requires early internal assessment plus strong technical capability, agility, advocacy, clear communication, and long‑term alignment to meet evolving cell and gene therapy needs.
Engineering The Next Wave Of CHO Performance
By combining improved productivity with speed and reliability, S-CHOice® 2G helps biopharmaceutical companies optimize their manufacturing strategies, reduce overall costs, and respond more effectively to market demands.
The 5 Ws Of A Human Factors Strategy
A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.